Gemcitabine Hydrochloride

Gemcitabine Hydrochloride Manufacturers

• Heritage Pharmaceuticals Inc.
  

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  Gemcitabine Hydrochloride | Heritage Pharmaceuticals Inc.

  

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  2.1 Ovarian Cancer

  Recommended Dose and Schedule The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemcitabine for Injection USP administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information. Dose Modifications Recommended Gemcitabine for Injection USP dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for injection USP for Myelosuppression on Day of Treatment in Ovarian Cancer Treatment Day
  Absolute granulocyte count
  (x 106/L) 
  
  Platelet count
   (x 106/L) 
  % of full dose
  Day 1
  ≥1500
  <1500
  and
  or
  ≥100,000
  <100,000
  100%
  Delay Treatment Cycle
  Day 8
  ≥1500
  1000-1499
  <1000
  and
  or
  or
  ≥100,000
  75,000-99,999
  <75,000
  100
  50
  Hold
  Table 2: Gemcitabine for Injection USP Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer Occurrence
  Myelosuppression During Treatment Cycle
  Dose Modification
  Initial Occurrence
  Absolute granulocyte count less than 500 x 106/L for more
  than 5 days
  Absolute granulocyte count less than 100 x 106/L for more 
  than 3 days
  Febrile neutropenia
  Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity 
  Permanently reduce Gemcitabine for Injection USP to 800 mg/m2 on Days 
  1 and 8 
  Subsequent Occurrence
  If any of the above toxicities occur after the initial dose 
  reduction
  Permanently reduce Gemcitabine for Injection USP dose to 800 mg/m2 on 
  Day 1 only 
  2.2 Breast Cancer

  Recommended Dose and Schedule The recommended dose of Gemcitabine for Injection USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before Gemcitabine for Injection USP administration. Dose Modifications Recommended dose modifications for Gemcitabine for Injection USP for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Injection USP for Myelosuppression on Day of Treatment in Breast Cancer Treatment Day
  
  Absolute granulocyte count
  (x 106/L) 
  
  
  Platelet count
  (x 106/L) 
  % of full dose
  Day 1
  ≥1500
  and
  ≥100,000
  100%
  
  less than 1500
  or
  less than 100,000
  Hold
  Day 8
  ≥1200
  and
  >75,000
  100%
  
  1000-1199
  or
  50,000-75,000
  75%
  
  700-999
  and
  ≥50,000
  50%
  
  <700
  or
  <50,000
  Hold
  2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP.

  Every 3-week schedule

  The recommended dose of Gemcitabine for Injection USP is 1250 mg/m2intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection USP myelosuppression are described in Table 4 [see Warnings and Precautions(5.2)]. Refer to Dosage and Administration (2.5) for Gemcitabine for Injection USP recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest. After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection USP for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving Gemcitabine for Injection USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Injection USP for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute granulocyte count
  (x 106/L) 
  
  Platelet count
  (x 106/L) 
  % of full dose
  ≥1000
  And
  ≥100,000
  100
  500-999
  Or
  50,000-99,999
  75
  <500
  Or
  <50,000
  Hold
  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for Injection USP for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome Posterior reversible encephalopathy syndrome

  Withhold Gemcitabine for Injection USP or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemcitabine for Injection USP go to "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA.http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a gemcitabine concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted gemcitabine is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• Pfizer Laboratories Div Pfizer Inc.
  

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  Gemcitabine Hydrochloride | Pfizer Laboratories Div Pfizer Inc.

  

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  Gemcitabine for Injection is for intravenous use only. Gemcitabine for Injection may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine for Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications  

  Gemcitabine for Injection dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  ≥1500        
  and
  ≥100,000
  100
  1000-1499
  and/or
  75,000-99,999
  50
  <1000
  And/or
  <75,000
  Hold
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine for Injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for Gemcitabine for Injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine for Injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days Absolute granulocyte count <100 x 106/L for more than 3 days Febrile neutropenia Platelets <25,000 x 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine for Injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine for Injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for Injection dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Paclitaxel Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  ≥1200        
  and
  >75,000
  100
  1000-1199
  or
  50,000-75,000
  75
  700-999
  and
  ≥50,000
  50
  <700
  or
  <50,000
  Hold
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine for Injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection. With the 3-week schedule, Gemcitabine for Injection should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine for Injection on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine for Injection and for cisplatin. Gemcitabine for Injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine for Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for Gemcitabine for Injection plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine for Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)]. Patients receiving Gemcitabine for Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  ≥1000      
  and
  ≥100,000
  100
  500-999
  or
  50,000-99,999
  75
  <500
  or
  <50,000
  Hold
  

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine for Injection who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine for Injection at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine for Injection solutions. The use of gloves is recommended. If Gemcitabine for Injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of Gemcitabine for Injection is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for Gemcitabine for Injection upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial or 50 mL of 0.9% Sodium Chloride Injection to the 2-g vial . Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial or 1.3 mL for the 1-g vial or 2.6 mL for the 2-g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL or 52.6 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g or 2 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, Gemcitabine for Injection solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted Gemcitabine for Injection should not be refrigerated, as crystallization may occur.

  The compatibility of Gemcitabine for Injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• Watson Laboratories, Inc.
  

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  Gemcitabine Hydrochloride | Watson Laboratories, Inc.

  

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        Gemcitabine for injection is for intravenous use only. Gemcitabine for injection may be administered on an outpatient basis.

  2.1       Ovarian Cancer

        Gemcitabine for injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

        Gemcitabine for injection dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin Absolute granulocyte count Platelet count % of full dose (x 106/L) (x 106/L) ≥1500 And ≥100,000 100 1000 to 1499 and/or 75,000 to 99,999 50 <1000 and/or <75,000 Hold

        In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer’s prescribing information.

        Dose adjustment for gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine for injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days
  Absolute granulocyte count <100 x 106/L for more than 3 days
  Febrile neutropenia
  Platelets <25,000 x 106/L
  Cycle delay of more than one week due to toxicity

        If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine for injection should be given on Day 1 only at 800 mg/m2.

  2.2       Breast Cancer

        Gemcitabine for injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

        Gemcitabine for injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, gemcitabine for injection dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Paclitaxel Absolute granulocyte count Platelet count % of full dose (x 106/L) (x 106/L) ≥1200 And >75,000 100 1000 to 1199 Or 50,000 to 75,000 75 700 to 999 And ≥50,000 50 <700 Or <50,000 Hold

        In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3       Non-Small Cell Lung Cancer

        Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, gemcitabine for injection should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine for injection. With the 3-week schedule, gemcitabine for injection should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of gemcitabine for injection on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

        Dosage adjustments for hematologic toxicity may be required for gemcitabine for injection and for cisplatin. Gemcitabine for injection dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

        In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine for injection plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine for injection plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4       Pancreatic Cancer

        Gemcitabine for injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

        Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

        Patients receiving gemcitabine for injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines Absolute granulocyte count Platelet count % of full dose (x 106/L) (x 106/L) ≥1000 And ≥100,000 100 500 to 999 Or 50,000 to 99,999 75 <500 Or <50,000 Hold

        Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

        Patients treated with gemcitabine for injection who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of gemcitabine for injection at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5       Preparation and Administration Precautions

        Caution should be exercised in handling and preparing gemcitabine for injection solutions. The use of gloves is recommended. If gemcitabine for injection solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

        Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.6       Preparation for Intravenous Infusion Administration

        The recommended diluent for reconstitution of gemcitabine for injection is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for gemcitabine for injection upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

        To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial or 1.3 mL for the 1-g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

        Reconstituted gemcitabine for injection is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.

        When prepared as directed, gemcitabine for injection solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted gemcitabine for injection should not be refrigerated, as crystallization may occur.

        The compatibility of gemcitabine for injection with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• App Pharmaceuticals, Llc
  

  ×

  Gemcitabine Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  Gemcitabine for Injection is for intravenous use only.  Gemcitabine may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.  Carboplatin AUC 4 should be administered intravenously on Day 1 after gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts.  Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle. 

  Dose Modifications

  Gemcitabine for Injection dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy.  If marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in Table 1.  

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin

  Absolute granulocyte count

  (x 106/L)

  Platelet count

  (x 106/L)

  % of full dose

   ≥ 1500

  And

    ≥ 100,000

  
  

  100

  1000 to 1499

  and/or

  75,000 to 99,999

  50

  <1000

  and/or

  <75,000

  Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician.  For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity.  The dose of gemcitabine for injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:  

               •   Absolute granulocyte count <500 x 106/L for more than 5 days

               •   Absolute granulocyte count <100 x 106/L for more than 3 days

               •   Febrile neutropenia

               •   Platelets <25,000 x 106/L

               •   Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine for injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.  Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before gemcitabine administration.  Patients should be monitored prior to each dose with a complete blood count, including differential counts.  Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle. 

  Dose Modifications

  Gemcitabine dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy.  If marrow suppression is detected, gemcitabine dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine in Combination with Paclitaxel

  Absolute granulocyte count

  (x 106/L)

  Platelet count

  (x 106/L)

  % of full dose

  ≥ 1200

  And

  > 75,000

  100

  1000 to 1199

  Or

  50,000 to 75,000

  75

  700 to 999

  And

  ≥ 50,000

  50

  < 700

  Or

  < 50,000

  Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician.  For paclitaxel dosage adjustment, see manufacturer’s prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.  Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine.  With the 3-week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of gemcitabine on Day 1.  See prescribing information for cisplatin administration and hydration guidelines. 

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin.  Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts.  If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.  For cisplatin dosage adjustment, see manufacturer’s prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician.  During combination therapy with  cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine plus cisplatin was 5% versus 2% for cisplatin alone). 

  2.4 Pancreatic Cancer

  Gemcitabine for Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment.  Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.  If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines

  Absolute granulocyte count

  (x 106/L)

  Platelet count

  (x 106/L)

  % of full dose

  ≥ 1000

  And

  ≥ 100,000

  100

  500 to 999

  Or

  50,000 to 99,999

  75

  < 500

  Or

  < 50,000

  Hold

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter.  Gemcitabine for Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations. 

  Patients treated with gemcitabine who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 106/L and 100,000 x 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1.  If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x106/L and 100,000 x 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing gemcitabine solutions.  The use of gloves is recommended.  If gemcitabine solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered.  Several guidelines on this subject have been published [see References (15)].

  2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of gemcitabine is 0.9% Sodium Chloride Injection without preservatives.  Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/mL.  Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200 mg vial, 25 mL of 0.9% Sodium Chloride Injection to the 1g vial or 50 mL of 0.9 % Sodium Chloride Injection to the 2 gram vial.  Shake to dissolve.  These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200 mg vial, 1.3 mL for the 1g vial or 2.6 mL for the 2 gram vial).  The total volume upon reconstitution will be 5.26 mL, 26.3 mL or 52.6 mL, respectively.  Complete withdrawal of the vial contents will provide 200 mg, 1 g or 2 grams of gemcitabine, respectively.  Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL. 

  Reconstituted gemcitabine is a clear, colorless to light straw-colored solution.  After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3.  The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit.  If particulate matter or discoloration is found, do not administer. 

  When prepared as directed, gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Discard unused portion.  Solutions of reconstituted gemcitabine should not be refrigerated, as crystallization may occur.

  The compatibility of gemcitabine with other drugs has not been studied.  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• App Pharmaceuticals, Llc
  

  ×

  Gemcitabine Hydrochloride | App Pharmaceuticals, Llc

  

  ---

  
  Gemcitabine for Injection is for intravenous use only. Gemcitabine may be administered on an outpatient basis. 2.1 Ovarian Cancer
  

  Gemcitabine for Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts.  Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for Injection dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin

  Absolute granulocyte count
  (x 106/L)   Platelet count
  (x 106/L) % of full dose  ≥ 1500
  And
  ≥ 100,000
  100
  1000 to 1499
  and/or
  75,000 to 99,999
  50
  < 1000
  and/or
  < 75,000
  Hold
  

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician.  For carboplatin dosage adjustment, see manufacturer’s prescribing information.

  Dose adjustment for gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine for injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 x 106/L for more than 5 days Absolute granulocyte count <100 x 106/L for more than 3 days Febrile neutropenia Platelets <25,000 x 106/L Cycle delay of more than one week due to toxicity If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine for injection should be given on Day 1 only at 800 mg/m 2. 2.2 Breast Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.  Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts.  Patients should have an absolute granulocyte count ≥1500 x 106/L and a platelet count ≥100,000 x 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy.  If marrow suppression is detected, gemcitabine dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine in Combination with Paclitaxel

  
  Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose  ≥ 1200
  And
  > 75, 000 
  100
  1000 to 1199
  Or
  50,000 to 75,000
  75
  700 to 999
  And
  ≥ 50,000
  50
  < 700
  Or
  <50,000
  Hold
  
  
  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician.  For paclitaxel dosage adjustment, see manufacturer’s prescribing information. 2.3 Non-Small Cell Lung Cancer
  

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine. With the 3-week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of gemcitabine on Day 1.  See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer’s prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine plus cisplatin was 5% versus 2% for cisplatin alone). 2.4 Pancreatic Cancer

  Gemcitabine for Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count.  If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  
  Table 3: Dosage Reduction Guidelines
  Absolute granulocyte count
  (x106/L) Platelet count
  (x106/L)  % of full dose   ≥ 1000
  And
   ≥ 100,000
  100
  500 to 999
  Or
  50,000 to 99,999
  75
  < 500
  Or
  < 50,000
  Hold
  

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter.  Gemcitabine for Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  
  Patients treated with gemcitabine who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 x 10 6/L and 100,000 x 10 6/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 x 10 6/L and 100,000 x 10 6/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1. 2.5 Preparation and Administration Precautions
  

  Caution should be exercised in handling and preparing gemcitabine solutions. The use of gloves is recommended.  If gemcitabine solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)]. 2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of gemcitabine is 0.9% Sodium Chloride Injection without preservatives.  Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/mL.  Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  
  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial, 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial or 50 mL of 0.9% Sodium Chloride Injection to the 2-g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial, 1.3 mL for the 1-g vial or 2.6 mL for the 2-g vial). The total volume upon reconstitution will be 5.26 mL, 26.3 mL or 52.6 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg, 1 g or 2 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.
  
  Reconstituted gemcitabine is a clear, colorless to light straw-colored solution.  After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3.  The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit.  If particulate matter or discoloration is found, do not administer.

  When prepared as directed, gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallization may occur.

  
  The compatibility of gemcitabine with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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• Teva Parenteral Medicines, Inc.
  

  ×

  Gemcitabine Hydrochloride | Teva Parenteral Medicines, Inc.

  

  ---

  Gemcitabine for Injection is for intravenous use only. Gemcitabine may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after gemcitabine for injection administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for Injection dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection in Combination with Carboplatin Absolute
  granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of
  full dose ≥1500 And ≥100,000 100 1000 to 1499 and/or 75,000 to 99,999 50 <1000 and/or <75,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with gemcitabine for injection should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer's prescribing information.

  Dose adjustment for gemcitabine for injection in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of gemcitabine for injection in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 × 106/L for more than 5 days Absolute granulocyte count <100 × 106/L for more than 3 days Febrile neutropenia Platelets <25,000 × 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, gemcitabine for injection should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine for Injection should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before gemcitabine administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine dosage adjustments for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, gemcitabine dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine in Combination with Paclitaxel Absolute
  granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of
  full dose ≥1200 And >75,000 100 1000 to 1199 Or 50,000 to 75,000 75 700 to 999 And ≥50,000 50 <700 Or <50,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer's prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, gemcitabine should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of gemcitabine. With the 3-week schedule, gemcitabine should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of gemcitabine on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for gemcitabine and for cisplatin. Gemcitabine dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer's prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with gemcitabine plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine for Injection should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology(12.3)].

  Patients receiving gemcitabine should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines Absolute
  granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of
  full dose ≥1000 And ≥100,000 100 500 to 999 Or 50,000 to 99,999 75 <500 Or <50,000 Hold

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for Injection should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with gemcitabine who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of gemcitabine at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing gemcitabine solutions. The use of gloves is recommended. If gemcitabine solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of gemcitabine is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for gemcitabine upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200 mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1 g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200 mg vial or 1.3 mL for the 1 g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted gemcitabine is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, gemcitabine solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallization may occur.

  The compatibility of gemcitabine with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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  More Info
• Hameln Rds Gmbh
  

  ×

  Gemcitabine Hydrochloride | Hameln Rds Gmbh

  

  ---

  Gemcitabine for Injection USP is for intravenous use only. Gemcitabine for Injection USP may be administered on an outpatient basis.

  2.1 Ovarian Cancer

  Gemcitabine for Injection USP should be administered intravenously at a dose of 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Carboplatin AUC 4 should be administered intravenously on Day 1 after Gemcitabine for Injection USP administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for InjectionUSP dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection USP dosage should be modified according to guidelines in Table 1.

  Table 1: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection USP in Combination with Carboplatin Absolute granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of full dose ≥1500 And ≥100,000 100 1000–1499 And/or 75,000–99,999 50 <1000 And/or <75,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except nausea/vomiting, therapy with Gemcitabine for Injection USP should be held or decreased by 50% depending on the judgment of the treating physician. For carboplatin dosage adjustment, see manufacturer's prescribing information.

  Dose adjustment for Gemcitabine for Injection USP in combination with carboplatin for subsequent cycles is based upon observed toxicity. The dose of Gemcitabine for Injection USP in subsequent cycles should be reduced to 800 mg/m2 on Days 1 and 8 in case of any of the following hematologic toxicities:

  Absolute granulocyte count <500 × 106/L for more than 5 days Absolute granulocyte count <100 × 106/L for more than 3 days Febrile neutropenia Platelets <25,000 × 106/L Cycle delay of more than one week due to toxicity

  If any of the above toxicities recur after the initial dose reduction, for the subsequent cycle, Gemcitabine for Injection USP should be given on Day 1 only at 800 mg/m2.

  2.2 Breast Cancer

  Gemcitabine for Injection USP should be administered intravenously at a dose of 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3-hour intravenous infusion before Gemcitabine for Injection USP administration. Patients should be monitored prior to each dose with a complete blood count, including differential counts. Patients should have an absolute granulocyte count ≥1500 × 106/L and a platelet count ≥100,000 × 106/L prior to each cycle.

  Dose Modifications

  Gemcitabine for Injection USP dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on Day 8 of therapy. If marrow suppression is detected, Gemcitabine for Injection USP dosage should be modified according to the guidelines in Table 2.

  Table 2: Day 8 Dosage Reduction Guidelines for Gemcitabine for Injection USP in Combination with Paclitaxel Absolute granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of full dose ≥1200 And >75,000 100 1000–1199 Or 50,000–75,000 75 700–999 And ≥50,000 50 <700 Or <50,000 Hold

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection USP should be held or decreased by 50% depending on the judgment of the treating physician. For paclitaxel dosage adjustment, see manufacturer's prescribing information.

  2.3 Non-Small Cell Lung Cancer

  Two schedules have been investigated and the optimum schedule has not been determined [see Clinical Studies (14.3)]. With the 4-week schedule, Gemcitabine for Injection USP should be administered intravenously at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. Cisplatin should be administered intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP. With the 3-week schedule, Gemcitabine for Injection USP should be administered intravenously at 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle. Cisplatin at a dose of 100 mg/m2 should be administered intravenously after the infusion of Gemcitabine for Injection USP on Day 1. See prescribing information for cisplatin administration and hydration guidelines.

  Dose Modifications

  Dosage adjustments for hematologic toxicity may be required for Gemcitabine for Injection USP and for cisplatin. Gemcitabine for Injection USP dosage adjustment for hematological toxicity is based on the granulocyte and platelet counts taken on the day of therapy. Patients receiving Gemcitabine for Injection USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet counts. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3. For cisplatin dosage adjustment, see manufacturer's prescribing information.

  In general, for severe (Grade 3 or 4) non-hematological toxicity, except alopecia and nausea/vomiting, therapy with Gemcitabine for Injection USP plus cisplatin should be held or decreased by 50% depending on the judgment of the treating physician. During combination therapy with cisplatin, serum creatinine, serum potassium, serum calcium, and serum magnesium should be carefully monitored (Grade 3/4 serum creatinine toxicity for gemcitabine plus cisplatin was 5% versus 2% for cisplatin alone).

  2.4 Pancreatic Cancer

  Gemcitabine for Injection USP should be administered by intravenous infusion at a dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles should consist of infusions once weekly for 3 consecutive weeks out of every 4 weeks.

  Dose Modifications

  Dosage adjustment is based upon the degree of hematologic toxicity experienced by the patient [see Warnings and Precautions (5.2)]. Clearance in women and the elderly is reduced and women were somewhat less able to progress to subsequent cycles [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

  Patients receiving Gemcitabine for Injection USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 3.

  Table 3: Dosage Reduction Guidelines Absolute granulocyte count
  (× 106/L) Platelet count
  (× 106/L) % of full dose ≥1000 And ≥100,000 100 500–999 Or 50,000–99,999 75 <500 Or <50,000 Hold

  Laboratory evaluation of renal and hepatic function, including transaminases and serum creatinine, should be performed prior to initiation of therapy and periodically thereafter. Gemcitabine for Injection USP should be administered with caution in patients with evidence of significant renal or hepatic impairment as there is insufficient information from clinical studies to allow clear dose recommendation for these patient populations.

  Patients treated with Gemcitabine for Injection USP who complete an entire cycle of therapy may have the dose for subsequent cycles increased by 25%, provided that the absolute granulocyte count (AGC) and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and if non-hematologic toxicity has not been greater than WHO Grade 1. If patients tolerate the subsequent course of Gemcitabine for Injection USP at the increased dose, the dose for the next cycle can be further increased by 20%, provided again that the AGC and platelet nadirs exceed 1500 × 106/L and 100,000 × 106/L, respectively, and that non-hematologic toxicity has not been greater than WHO Grade 1.

  2.5 Preparation and Administration Precautions

  Caution should be exercised in handling and preparing Gemcitabine for Injection USP solutions. The use of gloves is recommended. If Gemcitabine for Injection USP solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water. Although acute dermal irritation has not been observed in animal studies, 2 of 3 rabbits exhibited drug-related systemic toxicities (death, hypoactivity, nasal discharge, shallow breathing) due to dermal absorption.

  Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published [see References (15)].

  2.6 Preparation for Intravenous Infusion Administration

  The recommended diluent for reconstitution of Gemcitabine for Injection USP is 0.9% Sodium Chloride Injection without preservatives. Due to solubility considerations, the maximum concentration for Gemcitabine for Injection USP upon reconstitution is 40 mg/mL. Reconstitution at concentrations greater than 40 mg/mL may result in incomplete dissolution, and should be avoided.

  To reconstitute, add 5 mL of 0.9% Sodium Chloride Injection to the 200-mg vial or 25 mL of 0.9% Sodium Chloride Injection to the 1-g vial. Shake to dissolve. These dilutions each yield a gemcitabine concentration of 38 mg/mL which includes accounting for the displacement volume of the lyophilized powder (0.26 mL for the 200-mg vial or 1.3 mL for the 1-g vial). The total volume upon reconstitution will be 5.26 mL or 26.3 mL, respectively. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine, respectively. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection USP is a clear, colorless to light straw-colored solution. After reconstitution with 0.9% Sodium Chloride Injection, the pH of the resulting solution lies in the range of 2.7 to 3.3. The solution should be inspected visually for particulate matter and discoloration prior to administration, whenever solution or container permit. If particulate matter or discoloration is found, do not administer.

  When prepared as directed, Gemcitabine for Injection USP solutions are stable for 24 hours at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard unused portion. Solutions of reconstituted Gemcitabine for Injection USP should not be refrigerated, as crystallization may occur.

  The compatibility of Gemcitabine for Injection USP with other drugs has not been studied. No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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  2.1 Ovarian Cancer Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemcitabine for Injection, USP administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

  Dose Modifications

  Recommended Gemcitabine for Injection, USP dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for Injection, USP for Myelosuppression on Day of Treatment in Ovarian Cancer Treatment
  Day
  Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  Day 1
  ≥1500
  <1500
  and
  or
  ≥100,000
  <100,000
  100%
  Delay Treatment Cycle
  Day 8
  ≥1500
  1000-1499
  <1000
  and
  or
  or
  ≥100,000
  75,000-99,999
  <75,000
  100
  50
  Hold
  Table 2: Gemcitabine for Injection, USP Dose Modification for Myelosuppression in Previous Cycle in Ovarian Cancer Occurrence
  Myelosuppression During Treatment cycle
  Dose Modification
  Initial Occurrence
  Absolute granulocyte count less than 500 x 106/L 
  Permanently reduce Gemcitabine 
  
  for more than 5 days
  for Injection, USP to 800 mg/m2 on 
  
  Absolute granulocyte count less than 100 x 106/L
  Days 1 and 8
  
  for more than 3 days
  
  
  Febrile neutropenia
  
  
  Platelets less than 25,000x106/L
  
  
  Cycle delay of more than one week due to toxicity
  
  Subsequent Occurrence
  If any of the above toxicities occur after the initial 
  Permanently reduce Gemcitabine
  
  dose reduction
  for Injection, USP dose to 800 mg/m2
  
  
  on Day 1 only
  2.2 Breast Cancer Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before Gemcitabine for Injection, USP administration.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP for myelosuppression are described in Table.3 [see Warnings and Precautions (5.2)].

  Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Injection, USP for Myelosuppression on Day of Treatment in Breast Cancer Treatment day
  Absolute granulocyte count 
  (x 106 /L)
  
  Platelet count
  (x 106/L)
  % of full dose
  Day 1
  ≥1500
  and
  ≥100,000
  100%
  
  less than 1500
  or
  less than 100,000
  Hold
  Day 8
  ≥1200
  and
  >75,000
  100%
  
  1000-1199
  or
  50,000-75,000
  75%
  
  700-999
  and
  ≥50,000
      50%
  
  <700
  or
  <50,000
  Hold
  2.3 Non-Small Cell Lung Cancer Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection, USP.

  Every 3-week schedule

  The recommended dose of Gemcitabine for Injection, USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection, USP.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP myelosuppression are described in Table 4 [see Warnings and Precautions(5.2)]. Refer to Dosage and Administration (2.5) for Gemcitabine for Injection, USP recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection, USP is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule.

    Weeks 1-8: weekly dosing for the first 7 weeks followed by one week rest.   After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles. Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection, USP for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions. Patients receiving Gemcitabine for Injection, USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Injection, USP for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  ≥1000
  And
  ≥100,000
  100
  500-999
  Or
  50,000-99,999
  75
  <500
  Or
  <50,000
  Hold
  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for Injection, USP for any of the following

    Unexplained dyspnea or other evidence of severe pulmonary toxicity   Severe hepatic toxicity   Hemolytic-Uremic Syndrome   Capillary Leak Syndrome   Posterior reversible encephalopathy syndrome

  Withhold Gemcitabine for Injection, USP or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing Gemcitabine for Injection, USP solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine for Injection, USP contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemcitabine for Injection, USP go to "OSHA Hazardous Drugs" (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial or 50 mL to the 2-g vial. These dilutions each yield a Gemcitabine concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g or 2g of Gemcitabine. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection, USP is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for injection, USP solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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  2.1 Ovarian Cancer
  

  Recommended Dose and Schedule The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemcitabine for Injection USP administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information. Dose Modifications Recommended Gemcitabine for Injection USP dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  
  
  Table 1: Dosage Reduction Guidelines for Gemcitabine for injection USP for Myelosuppression on Day of Treatment in Ovarian Cancer Treatment Day Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose Day 1 ≥1500
  <1500 and
  or ≥100,000
  <100,000 100%
  Delay Treatment Cycle Day 8 ≥1500
  1000-1499
  <1000 and
  or
  or ≥100,000
  75,000-99,999
  <75,000 100
  50
  Hold
  
  

  Table 2: Gemcitabine for Injection USP Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer

  Occurrence Myelosuppression During Treatment Cycle Dose Modification Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia
  Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity Permanently reduce Gemcitabine for Injection USP to 800 mg/m2 on Days 1 and 8 Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce Gemcitabine for Injection USP dose to 800 mg/m2 on Day 1 only 2.2 Breast Cancer
  

  Recommended Dose and Schedule The recommended dose of Gemcitabine for Injection USP is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before Gemcitabine for Injection USP administration. Dose Modifications Recommended dose modifications for Gemcitabine for Injection USP for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
  
  Table 3: Recommended Dose Reductions for Gemcitabine for Injection USP for Myelosuppression on Day of Treatment in Breast Cancer

  
  
  
  Treatment Day
  Absolute granulocyte count
  (x 106/L)
  
  Platelet count
  (x 106/L)
  % of full dose
  Day 1
  ≥1500
  and
  ≥100,000
  100%
  
  less than 1500
  or
  less than 100,000
  Hold
  Day 8
  ≥1200
  and
  >75,000
  100%
  
  1000-1199
  or
  50,000-75,000
  75%
  
  700-999
  and
  ≥50,000
  50%
  
  <700
  or
  <50,000
  Hold
  
  2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP.

  Every 3-week schedule

  The recommended dose of Gemcitabine for Injection USP is 1250 mg/m2intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection USP.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection USP myelosuppression are described in Table 4 [see Warnings and Precautions(5.2)]. Refer to Dosage and Administration (2.5) for Gemcitabine for Injection USP recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer
  
  

  Recommended Dose and Schedule
  The recommended dose of Gemcitabine for Injection USP is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  
  Weeks 1 to 8: weekly dosing for the first 7 weeks followed by one week rest. After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.
  

  Dose Modifications
  Recommended dose modifications for Gemcitabine for Injection USP for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.
  Patients receiving Gemcitabine for Injection USP should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.
  
  Table 4: Recommended Dose Reductions for Gemcitabine for Injection USP for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer
  

  
  Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose ≥1000 And ≥100,000 100 500-999 Or 50,000-99,999 75 <500 Or <50,000 Hold
  
  
  2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for Injection USP for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome Posterior reversible encephalopathy syndrome

  Withhold Gemcitabine for Injection USP or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing gemcitabine solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if gemcitabine contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemcitabine for Injection USP go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA.http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration
  

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial. These dilutions each yield a gemcitabine concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg or 1 g of gemcitabine. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  
  

  Reconstituted gemcitabine is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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  2.1 Ovarian Cancer

  Recommended Dose and Schedule

        The recommended dose of Gemcitabine for Injection is 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 intravenously after Gemcitabine for Injection administration on Day 1 of each 21-day cycle. Refer to carboplatin prescribing information for additional information.

  Dose Modifications

  Recommended Gemcitabine for Injection dose modifications for myelosuppression are described Table 1 and Table 2 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 1: Dosage Reduction Guidelines for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Ovarian Cancer Treatment Day Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose Day 1 ≥1500
  <1500 and
  or ≥100,000
  <100,000 100%
  Delay Treatment Cycle Day 8 ≥1500
  1000-1499
  <1000 and
  or
  or ≥100,000
  75,000-99,999
  <75,000 100
  50
  Hold Table 2: Gemcitabine for Injection Dose Modification for Myelosuppression in Previous Cycle In Ovarian Cancer Occurrence Myelosuppression During Treatment Cycle Dose Modification Initial Occurrence Absolute granulocyte count less than 500 x 106/L for more than 5 days
  Absolute granulocyte count less than 100 x 106/L for more than 3 days
  Febrile neutropenia
  Platelets less than 25,000x106/L
  Cycle delay of more than one week due to toxicity Permanently reduce Gemcitabine for Injection to 800 mg/m2 on Days 1 and 8 Subsequent Occurrence If any of the above toxicities occur after the initial dose reduction Permanently reduce Gemcitabine for Injection dose to 800 mg/m2 on Day 1 only 2.2 Breast Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle that includes paclitaxel. Paclitaxel should be administered at 175 mg/m2 on Day 1 as a 3 hour intravenous infusion before Gemcitabine for Injection administration.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection for myelosuppression are described in Table 3 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Table 3: Recommended Dose Reductions for Gemcitabine for Injection for Myelosuppression on Day of Treatment in Breast Cancer Treatment Day Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose Day 1 ≥1500 and ≥100,000 100% less than 1500 or less than 100,000 Hold Day 8 ≥1200 and >75,000 100% 1000-1199 or 50,000-75,000 75% 700-999 and ≥50,000 50% <700 or <50,000 Hold 2.3 Non-Small Cell Lung Cancer

  Recommended Dose and Schedule

  Every 4-week schedule

  The recommended dose of Gemcitabine for Injection is 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection

  Every 3-week schedule

  The recommended dose of Gemcitabine for Injection is 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 in combination with cisplatin therapy. Administer cisplatin intravenously at 100 mg/m2 on Day 1 after the infusion of Gemcitabine for Injection.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection myelosuppression are described in Table 4 [[see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for Gemcitabine for Injection recommendations for non-hematologic adverse reactions.

  2.4 Pancreatic Cancer

  Recommended Dose and Schedule

  The recommended dose of Gemcitabine for Injection is 1000 mg/m2 over 30 minutes intravenously. The recommended treatment schedule

  Weeks 1-8: weekly dosing for the first 7 weeks followed by one week rest. After week 8: weekly dosing on Days 1, 8, and 15 of 28-day cycles.

  Dose Modifications

  Recommended dose modifications for Gemcitabine for Injection for myelosuppression are described in Table 4 [see Warnings and Precautions (5.2)]. Refer to Dosage and Administration (2.5) for recommendations for non-hematologic adverse reactions.

  Patients receiving Gemcitabine for Injection should be monitored prior to each dose with a complete blood count (CBC), including differential and platelet count. If marrow suppression is detected, therapy should be modified or suspended according to the guidelines in Table 4.

  Table 4: Recommended Dose Reductions for Gemcitabine for Injection for Myelosuppression in Pancreatic Cancer and Non-Small Cell Lung Cancer Absolute granulocyte count
  (x 106/L) Platelet count
  (x 106/L) % of full dose ≥1000 And ≥100,000 100 500-999 Or 50,000-99,999 75 <500 Or <50,000 Hold 2.5 Dose Modifications for Non-Hematologic Adverse Reactions

  Permanently discontinue Gemcitabine for Injection for any of the following

  Unexplained dyspnea or other evidence of severe pulmonary toxicity Severe hepatic toxicity Hemolytic-Uremic Syndrome Capillary Leak Syndrome Posterior reversible encephalopathy syndrome

  Withhold Gemcitabine for Injection or reduce dose by 50% for other severe (Grade 3 or 4) non-hematological toxicity until resolved. No dose modifications are recommended for alopecia, nausea, or vomiting.

  2.6 Preparation and Administration Precautions

  Exercise caution and wear gloves when preparing Gemcitabine for Injection solutions. Immediately wash the skin thoroughly or rinse the mucosa with copious amounts of water if Gemcitabine for Injection contacts the skin or mucus membranes. Death has occurred in animal studies due to dermal absorption. For further guidance on handling Gemcitabine for Injection go to “OSHA Hazardous Drugs” (refer to antineoplastic weblinks including OSHA Technical Manual) at OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

  2.7 Preparation for Intravenous Infusion Administration

  Reconstitute the vials with 0.9% Sodium Chloride Injection without preservatives.

  Add 5 mL to the 200-mg vial or 25 mL to the 1-g vial or 50 mL to the 2-g vial. These dilutions each yield a Gemcitabine for Injection concentration of 38 mg/mL. Complete withdrawal of the vial contents will provide 200 mg, 1 g or 2 g of Gemcitabine for Injection. Prior to administration the appropriate amount of drug must be diluted with 0.9% Sodium Chloride Injection. Final concentrations may be as low as 0.1 mg/mL.

  Reconstituted Gemcitabine for Injection is a clear, colorless to light straw-colored solution. Inspect visually prior to administration and discard for particulate matter or discoloration. Gemcitabine for Injection solutions are stable for 24 hours at controlled room temperature of 20° to 25°C (68° to 77°F). Do not refrigerate as crystallization can occur.

  No incompatibilities have been observed with infusion bottles or polyvinyl chloride bags and administration sets.

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